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Job Details

Clinical Quality Manager - Bucharest, Romania

Company: Covance
Location: Bucharest
Reference: 17284
Closing Date: 28 Feb 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

COVANCE is probably enhancing your quality of life without you even knowing it. We play an important role in bringing new therapies to market by helping to turn raw compounds into safe, effective, and approved drugs that help people live longer, more productive lives. 

Requirements:

At the moment we are looking for a new permanent, Bucharest office-based employee to join our outsourcing department in the role of Country Quality Manager.

You will be employed by Covance and allocated to work in the client's structure as a Quality Manager responsible for Romania and Bulgaria. 

 

Responsibilities:

Regulations & Processes:

  • Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
  • In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
  • Local expert for any quality-related local processes.
  • Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary).
  • Leads continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and supports or co-leads continuous improvements activities at the global/regional level.

Training:

  • Local training point of contact and the liaison between local country operations and Learning & Development (L&D).
  • In close cooperation with local country operations management, identifies / coordinates local training needs.
  • Supports local trainings (as needed).

Quality Control (QC) Activities:

  • In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes ensuring a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.
  • In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
  • On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).

Audits & Inspections:

  • Primary local point of contact for MRL Quality Assurance and Regulatory Agencies.
  • Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.
  • In cooperation with local country operations and/or headquarters, performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.
  • On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary) and develops local action plan (incl. sharing of results and training of local country operations, if required).

Quality / Compliance Issue Escalation:

  • Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
  • If indicated, escalates significant quality/compliance issues per company process and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.
  • Local POC for escalations of Privacy Breaches that occurred in clinical trials, or supports local POC for escalations of Privacy Breaches, if necessary.

Clinical Supplies GCP Investigations:

  • Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
  • Coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management

Vendor Qualification:

  • Leads local vendor qualifications and re-qualifications of locally selected GCTO vendors and supports solving of quality issues with locally selected vendors.
  • Supports the Quality Management System (QMS) assessment for global and local vendor qualifications and re-qualifications.

MRL Compliance Steward:

  • Supports implementation of divisional compliance initiatives and reporting at the local level.
  • Communicates compliance concerns to local legal/compliance department and/or MRL Compliance.
  • Global / Regional Key Initiatives / Projects
  • Supports global/regional key initiatives/projects upon request of the RCQM.

 

Education/Qualifications:

  • Bachelor's Degree or equivalent in relevant health care area.

 

Experience:

  • A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
  • Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
  • Demonstrated experience leading cross-functional teams of business professionals.
  • Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
  • Ideally, experience in managing audits and inspections.
  • Ideally, experience in coordinating and delivering training sessions.

 

Skills:

  • Superior oral and written communication and people management skills in an international environment.
  • Excellent project management and organizational skills.
  • Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
  • Ability to analyze, interpret, and solve complex problems.
  • Ability to think strategically, objectively and with creativity and innovation.
  • Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.

Apply for this job: Clinical Quality Manager - Bucharest, Romania

Contact Information:

Address:  Covance- Warsaw


Poland
Tel: 
Fax: 
Website:  Visit Our Web Site

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